免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

再製用Masimo脉搏血氧計（1859成人O2傳感器），再製用Masimo脉搏血氧計（1860兒童O2傳感器），再製用Masimo脉搏血氧計（1861嬰兒O2傳感器），再製用Masimo脉搏血氧計（1862成人O2傳感器），再製用Masimo脉搏血氧計（2317成人O2傳感器），再製用Masimo脉搏血氧計（2319嬰兒O2傳感器），再製用Masimo脉搏血氧計（2320成人O2傳感器），再製用Masimo脉搏血氧計（2328嬰兒O2

K 號：K211140 · 2022-03-08

申請人Stryker Sustainability Solutions
決定日期2022-03-08
產品代碼DQA
諮詢委員會履歷
決定相當於

器材摘要

Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2 is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Sustainability Solutions. It received FDA 510(k) clearance on 2022-03-08 under 510(k) number K211140. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2?

Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2 is a medical device that received FDA 510(k) clearance on 2022-03-08. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K211140.

When did Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2 receive FDA 510(k) clearance?

Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2 received FDA 510(k) clearance on 2022-03-08, under 510(k) number K211140.

Who is the listed applicant for Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2?

The FDA 510(k) record lists Stryker Sustainability Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2?

The FDA product code for Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2 is DQA.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Stryker Sustainability Solutions 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260636再製LigaSure XP Maryland 齒輪式封合器/分隔器，無納米塗層K250898再製HARMONIC 700剪刀（HAR723/再製HARMONIC 700，5mm 直徑剪刀，配備先進止血功能，長度23cm）；再製HARMONIC 700剪刀（HAR736/再製HARMONIC 700，5mm 直徑剪刀，配備先進止血功能，長度36cm）；再製HARMONIC 700剪刀（HAR745/再製HARMONIC 700，5mm 直徑剪刀，配備先進止血功能，長度45cm）K241758再處理RD SET Adt pulse oximeter sensor (4000)；再處理RD SET Pdt pulse oximeter sensor (4001)；再處理RD SET Inf pulse oximeter sensor (4002)；再處理RD SET Adt pulse oximeter sensor (4003)K241606再處理HARMONIC 1100剪刀，直徑5mm，長度20cm（HAR1120）；再處理HARMONIC 1100剪刀，直徑5mm，長度36cm（HAR1136）K233471再處理HARMONIC 1100剪刀，直徑5mm，長度20cm（HAR1120）；再處理HARMONIC 1100剪刀，直徑5mm，長度36cm（HAR1136）K231621再處理 ViewFlex Xtra ICE 球囊导管 (D087031)

查看所有 25 項裝置 →

相關器械（代碼：DQA）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K252821可重用成人SpO2夾式感測器（3m）（M1196A）；可重用成人SpO2夾式感測器（0.9m）（M1196T）Philips Medizin Systeme Böblingen GmbHK252655心脈血氧濃度計（PO-A2AO、PO-A2AT、PO-A3AO、PO-H1AO、PO-B1AO、PO-C5AO、PO-C5AT、PO-C6AO、PO-C6AT）Shenzhen Imdk Medical Technology Co., Ltd.K253887鼻翼SpO2感測器（989803205381）；鼻翼SpO2感測器（989803205391）；鼻翼Sp02感測器（989803205401）Philips Medizin SystemeK260931Unimed可重用手指夾式SpO2感測器（U403-49R及U103-49R）Unimed Medical Supplies, Inc.K252448AViTA脉搏血氧儀 (SP61)Avita CorporationK252805YUWELL®手指血氧計（YX105、YX106、YX110、YX310）Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

↑